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RAE IQ
Built for Medical Devices

Built for ANZ medical device manufacturers, distributors and service providers.

WHS / HSWA compliance, ISO 45001 + ISO 9001 alignment and an evidence trail that satisfies internal audit and TGA / Medsafe expectations on a shared footing.

Hazards we already know in medical devices
app.raeiq.com / hazards / medical_devices
HAZARD REGISTER3 typical
Medical Devices hazard library
You hold ISO 13485 for the product but your WHSMS sits in a WHSMS Gap AnalysisHigh
Your QMS audit programme runs like clockwork. Your safety auInternal Audit ProgrammeHigh
Officer due diligence is a board agenda item with no evidencNCR / CAPAMed
Medical Devices workflows

What medical devices teams use most.

Six modules that solve the work in front of you. The rest of the platform is one click away.

Legal requirements register
ISO 45001 cl. 6.1.3 obligations register with scheduled reviews and auto-update feed.
Training records
Course catalogue, sessions, attendees and competency sign-off.
Documents

Drafted most by medical devices teams

WHSMS Gap Analysis
Internal Audit Programme
NCR / CAPA
Management Review
Officer Verification Report
The work that keeps your safety lead up at night

From the people we built this for.

You hold ISO 13485 for the product but your WHSMS sits in a 12-year-old PDF.

How RAE IQ answers

Upload your WHSMS, get an Opus-level clause-by-clause gap report against ISO 45001 and the WHS Acts. Regenerate weak sections in place.

Your QMS audit programme runs like clockwork. Your safety audit programme is two Post-its.

How RAE IQ answers

ISO 9.2-aligned internal audit programme: schedule, AI-drafted checklists per process area, finding capture, CAPA linkage, audit report PDFs.

Officer due diligence is a board agenda item with no evidence behind it.

How RAE IQ answers

Quarterly attestation workflow, dd-actions register, board-grade Officer Verification Report covering all six s27 / s44 limbs.

Other industries

Not what you do?

Construction
High-risk work, contractor churn and principal contractor demands, managed in one place.
Healthcare
Psychosocial risk, sharps, manual handling and medication safety, without the consultancy invoice.
Aged Care
Psychosocial risk, resident-to-staff aggression, manual handling and Mental Health First Aider tracking — without a consultant.
Manufacturing
Plant, hazardous chemicals and isolation work, under one roof.

Built for medical devices from the regs up.

Join Australian businesses running their compliance on RAE IQ. 3 free documents, no credit card. The free tier covers a typical week for a sole trader.

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